Glucocorticoids With Antihistamines Versus Antihistamines in Acute Urticaria in Emergency

NCT ID: NCT02565680

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-02-28

Brief Summary

Acute urticaria is common and affected 12% of population. 400 patients come in department emergency of Toulouse each year and there aren't many studies in literature which evaluate the glucocorticoids treatment. The standard treatment of urticaria is antihistamines H1, but glucocorticoids treatment administered orally for short course would permit to increase quickly acute urticaria uncomplicated. Clinical trial, prospective randomized double blinded of adults with acute urticaria less 24 hours duration and no take treatment urticaria before.

Detailed Description

Acute urticaria is common and affected 12% of population. 400 patients come in department emergency of Toulouse each year and there aren't many studies in literature which evaluate the glucocorticoids treatment. Acute urticaria is pruritic and incapacitating for daily life. The standard treatment of urticaria is antihistamines H1, but glucocorticoids treatment administered orally for short course would permit to increase quickly acute urticaria uncomplicated. Clinical trial, prospective randomized double blinded of adults with acute urticaria less 24 hours duration and no take treatment urticaria before. One group randomized received 40mg of cortancyl and 1 pill of citerizine and another group randomized received 1 pill citerizine and placebo like cortancyl. Pharmacy hospital takes care of randomization. Pruritus evaluated with icth score and rash evaluated with nine rule of Wallace, the patient is evaluated in T0, one hour after and contacted by telephone at J2, J5, J15, J 21 itch score, Wallace extension, observance, side effects are asked him.

Conditions

Acute Urticaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

placebo

tablets of Xyzall 5mg/ day during 5 days + placebo 40mg/ day during 4 days

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Xyzall 5mg during 5 days + placebo 40mg during 4 days

prednisone

tablets of Xyzall 5 mg/j during 5 days + prednisone 40 mg/ day during 4 days

Group Type: EXPERIMENTAL

prednisone

Intervention Type: DRUG

Xyzall 5mg during 5 days + prednisone 40mg during 4 days

Interventions

placebo

Xyzall 5mg during 5 days + placebo 40mg during 4 days

Intervention Type: DRUG

prednisone

Xyzall 5mg during 5 days + prednisone 40mg during 4 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• adults
• urticaria rash no more 24 h duration and no take treatment for urticaria

Exclusion Criteria

• patients were presented severe anaphylaxis or taken antihistamines or glucocorticoids within 5 days of arrival at ED,
• severe infection
• pregnancy
• patients BPCO
• diabetics
• allergy corticosteroids
• refusal to comply
• participate an other study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline Barniol, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

CHU Toulouse

Toulouse, , France

Countries

France

References

Barniol C, Dehours E, Mallet J, Houze-Cerfon CH, Lauque D, Charpentier S. Levocetirizine and Prednisone Are Not Superior to Levocetirizine Alone for the Treatment of Acute Urticaria: A Randomized Double-Blind Clinical Trial. Ann Emerg Med. 2018 Jan;71(1):125-131.e1. doi: 10.1016/j.annemergmed.2017.03.006. Epub 2017 May 3.

Reference Type: RESULT

PMID: 28476259 (View on PubMed)

Other Identifiers

11 221 02

Identifier Type: -

Identifier Source: org_study_id